The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05884853
Collaborator
(none)
120
1
2
42.9
2.8

Study Details

Study Description

Brief Summary

"Social brain" refers to brain regions dedicated to processing social information and enabling us to recognize and evaluate others' mental states. The social brain hypothesis suggests that our brains evolve to navigate complex social systems. The social brain is hypothesized to consist of a distributed network including the posterior superior temporal sulcus (pSTS), the dorsal and ventral medial prefrontal cortices (dmPFC and vmPFC), ACC and posterior cingulate cortex (PCC), the amygdala, the orbital frontal cortex (OFC), and the fusiform gyrus (FG), TPJ, inferior occipital gyrus (IOG), and the insula. Each region serves distinct role while works together to support social processing, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PEERS
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
40 autistic adolescents are recruited with their care givers. Also, 40 healthy controls.40 autistic adolescents are recruited with their care givers. Also, 40 healthy controls.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Plasticity of Social Brain Network in Adults With Autism Spectrum Disorder
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASD group

autistic adolescents with their caregiver

Behavioral: PEERS
The Program for the Education and Enrichment of Relational Skills (PEERS®) studies is an evidence-based 16-week group-based social skill training program developed for adolescents and young adults with ASD.

Sham Comparator: Control group

healthy control without their caregiver

Behavioral: PEERS
The Program for the Education and Enrichment of Relational Skills (PEERS®) studies is an evidence-based 16-week group-based social skill training program developed for adolescents and young adults with ASD.

Outcome Measures

Primary Outcome Measures

  1. Autism Diagnostic Interview Revised, ADIR [16 weeks]

    Interview of the caregivers that covers most developmental and behavioral aspects of ASD. Range from 0 to 8, higher the score, worse the symptom.

  2. The Autism Diagnostic Observation Schedule, ADOS [16 weeks]

    Diagnosing and assess autism. Range from 0 to 8, higher the score, worse the symptom.

  3. Autism Spectrum Quotient [16 weeks]

    50 items, total score range from 0 to 50. Higher the score, worse the symptom

  4. Social responsiveness scale [16 weeks]

    65 items, higher the score, worse the syptom

  5. Quality of socialization questionnaire [16 weeks]

    12 items. Higher the score, better the fruquency and quality of socialization

  6. Empathy quotient [16 weeks]

    higher the score, worse the empathy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age between 18 and 50

  • diagnosed with ASD from licensed mental health or medical professional based on DSM5

  • have social problems

  • motivated to participate in the treatment

  • fluent in chinese

  • caregiver also fluent in chinese and motivated to participate

  • had a full-scale IQ > 70 on WAIS-IV

  • scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD.

Exclusion Criteria:
  • history of major mental illness, such as bipolar affective disorder, schizophrenia, psychosis, or neurological diseases

  • visual impairment and/or hearing impairement

  • any metal, electronic part that cannot be removed from the body, or being pregnant, which may not be able to use fMRI scan.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Zhongzheng Dist. Taiwan 100229

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05884853
Other Study ID Numbers:
  • 202012163RIND
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2023